Critical care patients often cannot breathe naturally and thus require positive pressure mechanical ventilation to artificially sustain breathing. In the typical treatment regimen, the patient requiring mechanical ventilation is intubated by inserting an endotracheal tube, or airway, through the mouth and into the trachea. The proximal end of the tube is then placed in fluid communication with a mechanical ventilator via an interposed T-fitting whereby positive airflow is provided for inspiration of the patient's lungs.
In order to ensure non-preferential airflow to each lung, the distal end of the endotracheal tube must terminate above the patient's carina of trachea. It is also important, in order to prevent injury, that the tube's distal end terminates below the patient's larynx. Because significant force is applied during ventilation of the patient, however, endotracheal tubes can accidentally become displaced or dislodged, often leading to inadvertent right mainstream bronchus intubation or accidental extubation. As a result of these well-recognized and potentially fatal complications, much attention has been devoted to the study of endotracheal intubation and, in particular, to the search for better methods for securely stabilizing a properly inserted airway.
The clinical standard methods for securing oral endotracheal tubes in non-burn patients have traditionally called for placing either adhesive tape or some type of strap on the tube and affixing it to the patient's face. Unfortunately, these seemingly simple methods often involve complicated techniques to ensure tube stabilization and are often associated with excoriation complications, such as abrasion or break in tissue integrity, in the patient's mouth, lip and facial regions. Because the intubation tends to result in failure to clear normal salivation, the moistened tape holding the tube often loosens, especially when exacerbated by also commonly present coughing and/or gag reflexes. This further contributes to the denuding of the skin, as the frequently loosened tape must usually be removed and replaced.
Of more serious concern, once the tape is loosened, the endotracheal tube is largely free to dislocate or dislodge, presenting serious risk to the patient. In addition to the risk incident tube displacement, any movement of the tube can potentially greatly increase the costs associated with critical care patient management. Reinsertion or repositioning of an endotracheal tube calls for physician intervention according to the majority of critical care hospital protocols. Added to the expense of an otherwise unnecessary physician intervention, most protocols also call for radiographic verification of tube displacement or of proper tube placement following reinsertion or repositioning, or of both. Such radiographic intervention not only increases critical care costs, it unnecessarily exposes the already acutely ill patient to the cumulative effects of X-rays if otherwise preventable. Finally, but further complicating airway management, repeated reinsertion of an endotracheal tube tends to become increasingly difficult due to laryngeal edema or spasms, potentially exacerbating all of the foregoing complications.
In recent years, clinicians have responded to disadvantages associated with taping methods by introducing various appliances that positively engage the endotracheal tube and are adapted to be securely affixed to the patient's head through harness-type arrangements. The typical appliance comprises a hardened plastic mouthpiece, usually specifically adapted to hold the tube, which is secured against the patient's oral and/or facial regions by fabric straps about the head and/or neck. These well-known tube holders have generally shown increased efficacy toward tube stability and decreased short-term occurrences of skin complication.
While most studies of short-term, e.g. four days or less, intubations show less skin deterioration associated with tube holders than with the traditional taping methods, the result is not generally extendable to longer duration intubations. Although most critical care protocols call for tracheostomy in those patients expected to require very long duration mechanical ventilation, many long-term critical care patients nonetheless receive mechanical ventilation through an oral airway because of the difficulty in predicting the duration of required ventilation. As a consequence, long-term critical care patients often inadvertently become exposed to complications of extended oral mechanical ventilation in spite of existing protocol. The hardened plastic mouthpiece, even when padded, generates a significant interface pressure against the patient's oral and/or facial regions when adequately secured. As a result, the longer-term patient typically develops ulceration or pressure sores, often leading to infection and/or necrosis of tissues, in the oral and/or facial regions. Because these advanced skin complications are generally considered far more severe than those typically associated with taping methods, the longer duration critical care patient is often transitioned back to taping methods for stabilization of the endotracheal tube.
Transition back to taping methods unfortunately places the patient at significantly increased risk for complications associated with tube dislocation and accidental extubation. Notwithstanding the seriousness of tube dislocation and accidental extubation, and the enormous effort heretofore expended toward improving airway management, most researchers have all but conceded that no best method may exist. The general consensus rather concludes that a tradeoff between keeping the tube in place and effectively managing complications of the skin must be made. In stark contrast to this state of the art, it is an overriding object of the present invention to improve upon the prior art by providing a method and apparatus whereby complications of the skin in the oral and facial regions may be effectively managed without sacrificing stability in tube placement, in patients requiring extended periods of intubation as well as those intubated for normally expected duration.
It is a further object of the present invention to provide such an improved endotracheal tube holder which allows open access to the patient's mouth for oral hygiene, provides maximum patient comfort and is easy to use.
It is another object of the present invention to provide such an improved endotracheal tube holder which contributes to an overall reduction in the costs generally associated with critical care patient management, such as those resultant physician intervention and radiographic services, while nonetheless contributing to improved overall patient outcome.
It is yet another object of the present invention to provide such an improved endotracheal tube holder which is compact in size, reducing as much as possible the emotional trauma experienced by the critical care patient's family upon viewing the complex of treatment modalities generally required in the critical care scenario.
Finally, many other objects of the present invention will be apparent to those of ordinary skill in the relevant arts in light of the foregoing discussion and the following drawings, exemplary detailed description and appended claims.